Methylphenidate Studies for Drug Abuse Vulnerability Molecular Genentics

Stopped early

Conditions studied: Substance Abuse

In brief

Background: * Research has shown that several human genes have been associated with vulnerability to substance abuse and dependence. However, little is known about how people with these genetic tendencies react to drugs in controlled settings. * Methylphenidate, also known as Ritalin, is commonly prescribed for a number of conditions, including attention deficit disorder. Because methylphenidate is widely used in studies of brain chemistry and behavior and has relatively low risks associated with it use, researchers are interested in seeing how it affects the thinking processes of people with apparent genetic vulnerability to drug abuse. Objectives: \- To evaluate whether individuals with apparent genetic vulnerability to drug abuse react differently to methylphenidate than people who do not have this vulnerability. Eligibility: \- Individuals at least 18 years of age or older who have participated in the NIDA protocol Allelic Linkage in Substance Abuse. Design: * Participants will be asked to avoid using a number of over-the-counter medications, including antihistamines, cough medicines, and nasal decongestants, for 24 hours before the study day. Participants will also be asked to avoid consuming caffeinated beverages, nicotine or tobacco products, or alcohol on the morning of the day of the study, and will provide a urine sample at the start of the study to be tested for chemicals that may interfere with the study. * Because of the nature of the study drug, participants will not be allowed to drive to the clinical center on the day of the study. (Return transportation will be arranged.) * At the start of the study, participants will take two tablets (each 1 hour apart), and will not be told whether the tablets are the study drug or a placebo. * Participants will give regular answers to questions about mood and thinking processes on a computer for approximately 5 hours. Blood samples will be taken during this part of the study.

Key facts

Study ID

NCT00247689

Run by

National Institute on Drug Abuse (NIDA)

People needed

31

Starts

2004-12-22

Expected to finish

2015-02-27

Last updated by the study team

2019-12-12

Who can join

Age: 21 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Do NOT have a history of
• Seizures,
• Head injury resulting in unconsciousness and/or requiring hospitalization
• Cardiovascular abnormalities (i.e. murmur)
• Uncontrolled or untreated hypertension
• Diastolic >95 mmHg and/or Systolic > 145 mmHg
• Clinically significant anxiety, depression, and/or panic disorder
• Coronary artery disease.
• History of known coronary artery disease,
• History of a prior myocardial infarction or stroke.
• An 12 lead EKG will be done during screening (no more than three months prior to enrollment), reviewed by an M.D, and may be sent to an outside cardiologist for manual reading.
• EKG abnormalities which will EXCLUDE a subject will include the following: QTc interval > 450 ms or changes suggesting acute ischemia, second or third degree heart block, left bundle branch block, atrial fibrillation, signs of left ventricular hypertrophy or other clinically important arrhythmias.
• Dependence on methylphenidate or a psychostimulant
• History of an adverse reaction to cocaine, methylphenidate, amphetamine, other psychostimulant, herb and/or over the counter medication
• Urine sample positive for a psychostimulant on the day of the study. (An observed urine specimen will be tested on the day of the study)
• Clinically significant abnormal renal and/or liver function
• Renal (lab cut off ): BUN > 35mg/dl; Cr > 2.0 mg/dl
• Liver (lab cut off): AST > 200 U/L; ALT >200 U/L; Alk P > 200 U/L; GGT> 400 U/L
• Diagnosed with a movement disorder
• Diagnosed with glaucoma
• Currently taking any of the following: monoamine oxidase inhibitors (within 2 weeks of protocol participation), insulin, and/or a psychostimulant
• A major medical diagnosis (i.e. .stroke, rheumatoid arthritis on therapy, diabetes)
• Competent to give informed consent. Competency of research participation at the NIDA will be determined by a Shipley Institute of Living Scales estimated IQ score of 80 or greater and an SCL-90-R Global Severity Index T-score of 70 or less. Cognitive impairment will be defined using the Shipley Institute of Living Scale or WRAT (equivalent to WAIS-R IQ < 79). With individuals having SCL-90-R scores greater than 70 referred for evaluation to a Counselor or Physician before admission to the study can be complete. The counselor or physician using his/her clinical judgment will make 1 of 2 determinations: a) The applicant may continue with the screening process; b) The applicant is disqualified from participation in the study and an appropriate referral is made if indicated.
• To evaluate the understanding of the study, its risk and benefits, and how to withdrawal from the study at anytime will be determined by a Consent Quiz score of 80 percent or greater (answering 8 of 10 questions correctly) in NIDA participants

Where it is running

• National Institute on Drug Abuse — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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